Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010335
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2001-02-02
Brief Title:
Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide Anti-thymocyte Globulin and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Pilot Study of High-Dose Immunosuppression Followed by Infusion of CD34-Selected Autologous or Syngeneic Peripheral Blood Stem Cells for Treatment of Refractory Autoimmune Disorders
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide anti-thymocyte globulin and autologous CD34-selected peripheral blood stem cell PBSC transplantation in children with refractory autoimmune disorders
II Determine the efficacy of this treatment regimen in these patients III Determine the reconstitution of immunity after autologous CD34-selected PBSC transplantation in these patients
IV Determine engraftment of autologous CD34-selected PBSC in these patients
II Determine the efficacy of this treatment regimen in these patients III Determine the reconstitution of immunity after autologous CD34-selected PBSC transplantation in these patients
IV Determine engraftment of autologous CD34-selected PBSC in these patients
Detailed Description:
PROTOCOL OUTLINE This is a multicenter study Patients receive filgrastim G-CSF subcutaneously daily until peripheral blood stem cell PBSC collection is completed CD34 cells are separated from the rest of the PBSCs
Patients undergo total body irradiation twice daily on days -5 and -4 Patients receive anti-thymocyte globulin IV on days -5 -3 -1 1 3 and 5 and cyclophosphamide IV on days -3 and -2 CD34-selected PBSCs are reinfused on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Patients are followed annually for 5 years and then every 5 years thereafter
Patients undergo total body irradiation twice daily on days -5 and -4 Patients receive anti-thymocyte globulin IV on days -5 -3 -1 1 3 and 5 and cyclophosphamide IV on days -3 and -2 CD34-selected PBSCs are reinfused on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover
Patients are followed annually for 5 years and then every 5 years thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19915575 | OTHER | ORD | None |
| FHCRC-135300 | None | None | None |